IA Trial Radar | ||
|---|---|---|
L'essai clinique NCT07248774 pour Épanchement pleural est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
Effect of Bubble Positive Expiratory Pressure and Segmental Breathing Versus Incentive Spirometry in Pleural Effusion
Conducted as a randomized clinical trial, this study will include 40 pediatric participants aged 5-16, recruited from Gulab Devi Chest Hospital and Children's Hospital, Lahore. Participants will be randomly divided into two groups: one receiving Bubble PEP with Segmental Breathing and the other using Incentive Spirometry, both combined with conventional chest physiotherapy and mobility. Outcome measures, including lung expansion (via X-ray), dyspnea (assessed using the Pediatric Dyspnea Scale), chest expansion (measured with a measuring tape), oxygen saturation (SpO₂), and respiratory rate, will be recorded pre- and post-intervention. The study hypothesises that the Bubble PEP and Segmental Breathing approach may offer a cost-effective and efficient alternative to Incentive Spirometry, particularly for patients who cannot afford mechanical devices. Statistical analysis will be performed using SPSS version 2023 to determine the intervention's effects.
Effect of Bubble Positive Expiratory Pressure and Segmental Breathing Versus Incentive Spirometry on Lung Expansion and Dyspnea in Children With Pleural Effusion
- REC/RCR&AHS/TAYYBABARI
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifGroup A: Intervention Group (Bubble PEP + Segmental Breathing) The experimental group will receive Bubble PEP therapy and Segmental Breathing along with conventional chest physiotherapy and mobility training. Bubble PEP will be performed using a bottle device where children exhale through a water-submerged tube, creating resistance to improve lung expansion and secretion clearance (10 repetitions, progressing from 1 to 3 sets over 14 days). Segmental Breathing will focus on localized lung expansion with therapist-guided tactile feedback, performed at six breaths per minute, progressing from 1 to 3 sets. Chest percussion will be applied for 2-5 minutes with rest intervals, and walking distance will increase from 1 to 5 meters. All sessions will be conducted once daily for two weeks. | Bubble PEP Bubble PEP will be performed using a bottle device with 10 repetitions, progressing from one to three sets over 14 days. Segmental Breathing will target localized lung expansion with six breaths per minute, progressing similarly. Chest percussion will be applied on the contralateral side for 2-5 minutes with rest intervals, and walking distance will increase from 1 to 5 meters across the intervention period. All sessions will be conducted once daily for two weeks, with pre- and post-intervention assessments of lung expansion and dyspnea. |
Comparateur actifGroup B: Control Group (Incentive Spirometry) Participants in the control group will receive Incentive Spirometry along with conventional chest physiotherapy and mobility training. Incentive Spirometry will be used to encourage sustained maximal inspiration, thereby promoting lung expansion and improving ventilation. Each session will include three repetitions per side during Days 1-3, five repetitions per side during Days 4-7, and ten repetitions per side during Days 8-14, performed in one set per session. Chest percussion will be administered on the contralateral side to facilitate secretion mobilization, performed for two minutes on Days 1-3, three minutes on Days 4-7, and five minutes on Days 8-14, with 15 seconds of rest after each minute. Mobility training will include walking exercises, starting from one meter on Day 1, increasing to three meters by Day 3, and progressing to five meters from Day 4 onward, performed in two sets during Days 8-14. All sessions will be conducted once daily for two weeks. | Incentive Spirometery Incentive Spirometry will be used to encourage sustained maximal inspiration, thereby promoting lung expansion and improving ventilation. Each session will include three repetitions per side during Days 1-3, five repetitions per side during Days 4-7, and ten repetitions per side during Days 8-14, performed in one set per session. |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Lung Expansion | To assess lung expansion before and after the intervention, anteroposterior chest X-rays will be used to evaluate improvements in lung volume and potential reductions in pleural effusion. This method allows for the measurement of lung field dimensions, changes in the opacity of lung areas affected by pleural effusion, and overall changes in thoracic structure that might indicate therapeutic effectiveness. | Baseline, 2 weeks |
Pediatric Dyspnea Scale | The Pediatric Dyspnea Scale (PDS) assesses subjective dyspnea in pediatric patients by using a visual and numerical scale, where patients indicate their perception of breathlessness. The PDS is scored from 1 through 7 where 1 indicates "No trouble at all" breathing and 7 indicates "Very much trouble" and a score of 1 through 7 was assigned accordingly. | Baseline, 2 weeks |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Chest Expansion | Chest expansion will be measured with the help of tape method at different stages of the chest which measures symmetry and extent of expansion. The levels of measurements are at sternal notch, at xiphoid process and at T8vertebral level. | Baseline, 2 weeks |
Oxygen Saturation | Oxygen saturation (SpO2) will be measured using a pulse oximeter to evaluate improvements in oxygenation resulting from enhanced lung function. | Baseline, 2 weeks |
Respiratory Rate | The respiratory rate can be manually counted or evaluated using respiratory monitoring equipment, offering an objective measure of respiratory efficiency. | Baseline, 2 weeks |
- Age 5 to 16.
- Suffering from Pleural effusion or hydrothorax.
- Thoracic drainage system in situ for 24 hours.
- Either gender will be included.
- Patients without any other co-existing illness.
- Any other pulmonary pathology that does not fit the diagnostic criteria of Pleural Effusion.
- Participants with unbearable chest pain, chylothorax, hemothorax, pneumothorax, chest trauma or rib fracture.
- Participants with other comorbidities leading to pleural effusion.
- Patients who have chest musculoskeletal deformities.
Punjab Province